Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness.
OBJECTIVE: Assessment of the safety and efficacy of a 10-day melarsoprol schedule in second stage T.b. rhodesiense patients and the effect of suramin-pretreatment on the incidence of encephalopathic syndrome (ES) during melarsoprol therapy. DESIGN: Sequential conduct of a proof-of-concept trial (n =...
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ftdoajarticles:oai:doaj.org/article:ab31d3ab1c484a5e91bb041d54185ecc 2023-05-15T15:11:39+02:00 Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness. Irene Kuepfer Caecilia Schmid Mpairwe Allan Andrew Edielu Emma P Haary Abbas Kakembo Stafford Kibona Johannes Blum Christian Burri 2012-08-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0001695 https://doaj.org/article/ab31d3ab1c484a5e91bb041d54185ecc EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC3435133?pdf=render https://doaj.org/toc/1935-2735 1935-2735 doi:10.1371/journal.pntd.0001695 https://doaj.org/article/ab31d3ab1c484a5e91bb041d54185ecc PLoS Neglected Tropical Diseases, Vol 6, Iss 8, p e1695 (2012) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2012 ftdoajarticles https://doi.org/10.1371/journal.pntd.0001695 2022-12-31T01:29:34Z OBJECTIVE: Assessment of the safety and efficacy of a 10-day melarsoprol schedule in second stage T.b. rhodesiense patients and the effect of suramin-pretreatment on the incidence of encephalopathic syndrome (ES) during melarsoprol therapy. DESIGN: Sequential conduct of a proof-of-concept trial (n = 60) and a utilization study (n = 78) using historic controls as comparator. SETTING: Two trial centres in the T.b. rhodesiense endemic regions of Tanzania and Uganda. PARTICIPANTS: Consenting patients with confirmed second stage disease and a minimum age of 6 years were eligible for participation. Unconscious and pregnant patients were excluded. MAIN OUTCOME MEASURES: The primary outcome measures were safety and efficacy at end of treatment. The secondary outcome measure was efficacy during follow-up after 3, 6 and 12 months. RESULTS: The incidence of ES in the trial population was 11.2% (CI 5-17%) and 13% (CI 9-17%) in the historic data. The respective case fatality rates were 8.4% (CI 3-13.8%) and 9.3% (CI 6-12.6%). All patients discharged alive were free of parasites at end of treatment. Twelve months after discharge, 96% of patients were clinically cured. The mean hospitalization time was reduced from 29 to 13 days (p<0.0001) per patient. CONCLUSIONS: The 10-day melarsoprol schedule does not expose patients to a higher risk of ES or death than does treatment according to national schedules in current use. The efficacy of the 10-day melarsoprol schedule was highly satisfactory. No benefit could be attributed to the suramin pre-treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN40537886. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLoS Neglected Tropical Diseases 6 8 e1695 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
spellingShingle |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Irene Kuepfer Caecilia Schmid Mpairwe Allan Andrew Edielu Emma P Haary Abbas Kakembo Stafford Kibona Johannes Blum Christian Burri Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
OBJECTIVE: Assessment of the safety and efficacy of a 10-day melarsoprol schedule in second stage T.b. rhodesiense patients and the effect of suramin-pretreatment on the incidence of encephalopathic syndrome (ES) during melarsoprol therapy. DESIGN: Sequential conduct of a proof-of-concept trial (n = 60) and a utilization study (n = 78) using historic controls as comparator. SETTING: Two trial centres in the T.b. rhodesiense endemic regions of Tanzania and Uganda. PARTICIPANTS: Consenting patients with confirmed second stage disease and a minimum age of 6 years were eligible for participation. Unconscious and pregnant patients were excluded. MAIN OUTCOME MEASURES: The primary outcome measures were safety and efficacy at end of treatment. The secondary outcome measure was efficacy during follow-up after 3, 6 and 12 months. RESULTS: The incidence of ES in the trial population was 11.2% (CI 5-17%) and 13% (CI 9-17%) in the historic data. The respective case fatality rates were 8.4% (CI 3-13.8%) and 9.3% (CI 6-12.6%). All patients discharged alive were free of parasites at end of treatment. Twelve months after discharge, 96% of patients were clinically cured. The mean hospitalization time was reduced from 29 to 13 days (p<0.0001) per patient. CONCLUSIONS: The 10-day melarsoprol schedule does not expose patients to a higher risk of ES or death than does treatment according to national schedules in current use. The efficacy of the 10-day melarsoprol schedule was highly satisfactory. No benefit could be attributed to the suramin pre-treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN40537886. |
format |
Article in Journal/Newspaper |
author |
Irene Kuepfer Caecilia Schmid Mpairwe Allan Andrew Edielu Emma P Haary Abbas Kakembo Stafford Kibona Johannes Blum Christian Burri |
author_facet |
Irene Kuepfer Caecilia Schmid Mpairwe Allan Andrew Edielu Emma P Haary Abbas Kakembo Stafford Kibona Johannes Blum Christian Burri |
author_sort |
Irene Kuepfer |
title |
Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness. |
title_short |
Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness. |
title_full |
Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness. |
title_fullStr |
Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness. |
title_full_unstemmed |
Safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage Rhodesiense sleeping sickness. |
title_sort |
safety and efficacy of the 10-day melarsoprol schedule for the treatment of second stage rhodesiense sleeping sickness. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2012 |
url |
https://doi.org/10.1371/journal.pntd.0001695 https://doaj.org/article/ab31d3ab1c484a5e91bb041d54185ecc |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 6, Iss 8, p e1695 (2012) |
op_relation |
http://europepmc.org/articles/PMC3435133?pdf=render https://doaj.org/toc/1935-2735 1935-2735 doi:10.1371/journal.pntd.0001695 https://doaj.org/article/ab31d3ab1c484a5e91bb041d54185ecc |
op_doi |
https://doi.org/10.1371/journal.pntd.0001695 |
container_title |
PLoS Neglected Tropical Diseases |
container_volume |
6 |
container_issue |
8 |
container_start_page |
e1695 |
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1766342473265709056 |